Global Behavior and Periodontal Disease in Down's Syndrome Patients

NCT ID: NCT02941887

Last Updated: 2016-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-10-31

Brief Summary

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This study aimed at correlating global behavior of Down's Syndrome patients to periodontal disease status.

Detailed Description

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There is a higher prevalence and severity of periodontal disease in Down's Syndrome patients. Plaque levels in these patients are high due to poor hygiene habits. Behavior also may contribute to the overall periodontal condition.

Conditions

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Behavior Periodontal Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Down's Syndrome

Behavior analysis in Down's Syndrome patients

Behavior Analysis

Intervention Type BEHAVIORAL

One examiner observed global behavior of patients during a dental care session, guided by a behavioral scale.

Interventions

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Behavior Analysis

One examiner observed global behavior of patients during a dental care session, guided by a behavioral scale.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Down's Syndrome Diagnose characterized by the whole chromosomal aneuploidy 15 to 52 years
* Absence of severe hearing loss could impair the comprehension about the dental treatment
* Absence of severe visual loss that could impair the comprehension about the dental treatment
* Presence of at least four teeth being one for hemiarch.
* Diagnose of gingivitis and periodontitis
* Absence of acute periodontal disease and necrotizing periodontal disease.

Exclusion Criteria

* Smokers
* Use of alcohol
* Menopause
* Pregnancy
* Absence of all teeth
* Uncontrolled diabetes mellitus
* Uncontrolled hyperthyroidism
* Angina
* Uncontrolled hypertension
* Coagulopathy
* Use of illicit drugs
* Head and neck radiotherapy
* Chemotherapy
* Non-cooperative patients or patients with other diseases as autism.
Minimum Eligible Age

15 Years

Maximum Eligible Age

52 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Carla Andreotti Damante

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bauru School of Dentistry

Bauru, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Startin CM, Rodger E, Fodor-Wynne L, Hamburg S, Strydom A. Developing an Informant Questionnaire for Cognitive Abilities in Down Syndrome: The Cognitive Scale for Down Syndrome (CS-DS). PLoS One. 2016 May 6;11(5):e0154596. doi: 10.1371/journal.pone.0154596. eCollection 2016.

Reference Type BACKGROUND
PMID: 27153191 (View on PubMed)

Other Identifiers

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FOBDownSyndrome2

Identifier Type: -

Identifier Source: org_study_id

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